MyelofibrosisNCT05665192
A Study to Assess Real-World Patient-Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib
An observational study of Myelofibrosis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 24 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of participants who have discontinued RUX and will be initiating FEDR prospectively.
Who may be able to join
- Diagnosed with Primary myelofibrosis (PMF), post- Essential thrombocythemia (ET) Myelofibrosis (MF), or post- Polycythemia vera (PV) MF
- Treated with FEDR and initiated treatment after 16 August 2019.
- Received prior treatment with RUX.
- Had spleen assessed at time of initiation of FEDR by palpation.
- Able to read and speak English
- Willing to provide informed consent
- Willing to provide permission to the site to release her/his medical information to the study investigators according to the study-specific eCRF
- Willing to complete the baseline survey prior to first FEDR
Who cannot join
- Past or current participant in any FEDR-related clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardinal Health Specialty Solutions
Dublin, Ohio, 43017
About this study
Official title: Real-World Clinical and Patient Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib
The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.
- Conditions
- Myelofibrosis
- Keywords
- Primary Myelofibrosis, Thrombocythemia Myelofibrosis, Fedratinib, Ruxolitinib
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants that have discontinued RUX therapy and initiated FEDR prospectively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
Measured: Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
Absolute change in TSS assessed by MFSAF
Measured: At Baseline, 3 and 6 months post-FEDR initiation
Proportion of participants reporting individual symptoms in TSS assessed by MFSAF
Measured: At Baseline, 3 and 6 months post-FEDR initiation
Severity of each reported symptom in TSS assessed by MFSAF
Measured: At Baseline, 3 and 6 months post-FEDR initiation
Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC)
Measured: At Baseline, 3 and 6 months post-FEDR initiation
Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)
Measured: At Baseline, 3 and 6 months post-FEDR initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start2 Aug 2021
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665192
- Sponsor's protocol ID
- CA054-1014
- Status last verified
- Apr 2025
- First submitted
- 16 Dec 2022
- Last updated
- 8 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Clinical and Patient Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib
- ClinicalTrials.gov ID
- NCT05665192
- Acronym / sponsor ID
- CA054-1014
- Conditions
- Myelofibrosis
- Keywords
- Primary Myelofibrosis, Thrombocythemia Myelofibrosis, Fedratinib, Ruxolitinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants that have discontinued RUX therapy and initiated FEDR prospectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of participants who have discontinued RUX and will be initiating FEDR prospectively.
Key inclusion criteria (8 listed)
- Diagnosed with Primary myelofibrosis (PMF), post- Essential thrombocythemia (ET) Myelofibrosis (MF), or post- Polycythemia vera (PV) MF
- Treated with FEDR and initiated treatment after 16 August 2019.
- Received prior treatment with RUX.
- Had spleen assessed at time of initiation of FEDR by palpation.
- Able to read and speak English
Key exclusion criteria (1 listed)
- Past or current participant in any FEDR-related clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
Time frame: Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
Absolute change in TSS assessed by MFSAF
Time frame: At Baseline, 3 and 6 months post-FEDR initiation
Proportion of participants reporting individual symptoms in TSS assessed by MFSAF
Time frame: At Baseline, 3 and 6 months post-FEDR initiation
Severity of each reported symptom in TSS assessed by MFSAF
Time frame: At Baseline, 3 and 6 months post-FEDR initiation
Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC)
Time frame: At Baseline, 3 and 6 months post-FEDR initiation
Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)
Time frame: At Baseline, 3 and 6 months post-FEDR initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF) (time frame: Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.